Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. All information provided in this blog are obtained from FDA's In Vitro Diagnostic EUA and FAQs on Testing for SARS-CoV-2 pages.
In vitro (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:
Diagnostic Tests - Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
Serology/Antibody Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.
Tests for Management of COVID-19 Patients - Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.
Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's. NOTE: the table should be viewed in landscape mode on smaller handheld devices.
There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. Laboratories are also offering serology tests. Current lists of diagnostic and serology tests that fit into these categories are provided after the EUA table.
For more information on serology test performance, including sensitivity (true positive rate) and specificity (true negative rate), visit FDA's EUA Authorized Serology Test Performance page.
Date EUA Issued
|
Manufacturer
|
Letter of Authorization
|
Technology
|
Authorized Settings1
|
Authorization Documents2
| |
08/07/2020
|
George Washington University Public Health Laboratory
|
Molecular
|
H
| |||
08/06/2020
|
bioMérieux SA
|
IgM, ELFA
|
H, M
| |||
08/06/2020
|
bioMérieux SA
|
IgG, ELFA
|
H, M
| |||
08/06/2020
|
Helix OpCo LLC (dba Helix)
|
Molecular
|
H
| |||
08/05/2020
|
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
|
Total Antibody, ELISA
|
H
| |||
08/06/2020
|
Vela Operations Singapore Pte Ltd.
|
Molecular
|
H
| |||
08/03/2020
|
ISPM Labs, LLC dba Capstone Healthcare
|
Molecular
|
H
| |||
08/03/2020
|
Wren Laboratories LLC
|
Molecular
|
H
| |||
08/03/2020
|
Ethos Laboratories
|
Molecular, Home Collection
|
H
| |||
08/03/2020
|
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
|
Molecular
|
H
| |||
08/03/2020
|
Poplar Healthcare
|
Molecular, Sample Pooling
|
H
| |||
07/31/2020
|
Siemens Healthcare Diagnostics Inc.
|
IgG, Semi-quantitative
|
H, M
| |||
07/31/2020
|
Siemens Healthcare Diagnostics Inc.
|
IgG, Semi-quantitative
|
H, M
| |||
07/31/2020
|
Xiamen Zeesan Biotech Co., Ltd.
|
Molecular
|
H
| |||
07/31/2020
|
University of California San Diego Health
|
Molecular, Pooling
|
H
| |||
07/30/2020
|
Clinical Reference Laboratory, Inc.
|
Molecular, Home Collection
|
H
| |||
07/27/2020
|
Eli Lilly and Company
|
Molecular
|
H
| |||
07/27/2020
|
Sandia National Laboratories
|
Molecular
|
H
| |||
07/24/2020
|
Xiamen Biotime Biotechnology Co., Ltd.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/24/2020
|
Access Bio, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/24/2020
|
Jiangsu CoWin Biotech Co., Ltd.
|
Molecular
|
H
| |||
07/23/2020
|
Helix OpCo LLC (dba Helix)
|
Molecular
|
H
| |||
07/21/2020
|
DiaCarta, Inc.
|
Molecular
|
H
| |||
07/17/2020
|
Megna Health, Inc.
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/17/2020
|
Access Genetics, LLC
|
Molecular
|
H
| |||
07/16/2020
|
Boston Heart Diagnostics
|
Molecular
|
H
| |||
07/16/2020
|
Luminex Corporation
|
IgG, FMIA
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Molecular, Home Collection
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Molecular, Home Collection
|
H
| |||
07/15/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Molecular, Home Collection
|
H
| |||
07/13/2020
|
Salofa Oy
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/13/2020
|
KogeneBiotech Co., Ltd.
|
Molecular
|
H
| |||
07/13/2020
|
Trax Management Services Inc.
|
Molecular
|
H
| |||
07/13/2020
|
Compass Laboratory Services, LLC
|
Molecular, Home Collection
|
H
| |||
07/10/2020
|
Boston Medical Center
|
Molecular
|
H
| |||
07/10/2020
|
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd
|
Total Antibody, Lateral Flow
|
H, M
| |||
07/09/2020
|
UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin
|
Molecular
|
H
| |||
07/09/2020
|
BioSewoom, Inc.
|
Molecular
|
H
| |||
07/08/2020
|
Diazyme Laboratories, Inc.
|
IgG, CLIA
|
H, M
| |||
07/08/2020
|
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
|
Molecular
|
H
| |||
07/07/2020
|
Enzo Life Sciences, Inc.
|
Molecular
|
H
| |||
07/07/2020
|
Access Bio, Inc.
|
Molecular
|
H
| |||
07/07/2020
|
Gene By Gene
|
Molecular
|
H
| |||
07/06/2020
|
Assure Tech. (Hangzhou Co., Ltd)
|
IgM and IgG, Lateral Flow
|
H, M
| |||
07/06/2020
|
Laboratorio Clinico Toledo
|
Molecular
|
H
| |||
07/02/2020
|
Becton, Dickinson and Company (BD)
|
Antigen
|
H, M, W
| |||
07/02/2020
|
Centers for Disease Control and Prevention (CDC)
|
Molecular
|
H
| |||
07/01/2020
|
CENTOGENE US, LLC
|
Molecular
|
H
| |||
06/30/2020
|
InBios International, Inc.
|
IgM, ELISA
|
H
| |||
06/30/2020
|
Psomagen, Inc.
|
Molecular
|
H
| |||
06/30/2020
|
TNS Co., Ltd (Bio TNS)
|
Molecular
|
H
| |||
06/30/2020
|
The Kroger Co.
|
Home Collection Kit
| ||||
06/29/2020
|
LifeHope Labs
|
Molecular
|
H
| |||
06/26/2020
|
Beckman Coulter, Inc.
|
IgG , CLIA
|
H, M
| |||
06/26/2020
|
Inform Diagnostics, Inc.
|
Molecular
|
H
| |||
06/25/2020
|
Diagnostic Solutions Laboratory, LLC
|
Molecular
|
H
| |||
06/25/2020
|
PreciGenome LLC
|
Molecular
|
H
| |||
06/25/2020
|
PlexBio Co., Ltd.
|
Molecular
|
H
| |||
06/24/2020
|
University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory
|
Molecular
|
H
| |||
06/23/2020
|
HealthQuest Esoterics
|
Molecular
|
H
| |||
06/23/2020
|
University of Alabama at Birmingham Fungal Reference Lab
|
Molecular
|
H
| |||
06/23/2020
|
Gencurix, Inc.
|
Molecular
|
H
| |||
06/23/2020
|
Babson Diagnostics, Inc.
|
IgG , CLIA
|
H
| |||
06/19/2020
|
Hangzhou Laihe Biotech Co., Ltd.
|
IgM and IgG Lateral Flow
|
H, M
| |||
06/18/2020
|
Biohit Healthcare (Hefei) Co. Ltd.
|
IgM and IgG Lateral Flow
|
H, M
| |||
06/18/2020
|
Jiangsu Bioperfectus Technologies Co., Ltd.
|
Molecular
|
H
| |||
06/18/2020
|
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.
|
Molecular
|
H
| |||
06/17/2020
|
The Ohio State University Wexner Medical Center
|
Molecular
|
H
| |||
06/17/2020
|
Omnipath-ology Solutions Medical Corporation
|
Molecular
|
H
| |||
06/15/2020
|
Applied BioCode, Inc.
|
Molecular
|
H
| |||
06/15/2020
|
Emory Medical Laboratories
|
Serology IgG
|
H
| |||
06/13/2020
|
Kaiser Permanente Mid-Atlantic States
|
Molecular
|
H
| |||
06/12/2020
|
RTA Laboratories Biological Products Pharma-ceutical and Machinery Industry
|
Molecular
|
H
| |||
06/10/2020
|
InBios International, Inc.
|
Serology IgG
|
H
| |||
06/10/2020
|
Tide Laboratories, LLC
|
Molecular
|
H
| |||
06/10/2020
|
TBG Biotechnology Corp.
|
Molecular
|
H
| |||
06/10/2020
|
Cue Health Inc.
|
Molecular
|
H, W, M
| |||
06/09/2020
|
Illumina, Inc.
|
Molecular
|
H
| |||
06/09/2020
|
ChromaCode Inc.
|
Molecular
|
H
| |||
06/08/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
06/08/2020
|
Euroimmun US Inc.
|
Molecular
|
H
| |||
06/05/2020
|
Genetron Health (Beijing) Co., Ltd.
|
Molecular
|
H
| |||
06/04/2020
|
Vibrant America Clinical Labs
|
Serology IgM and IgG
|
H
| |||
06/04/2020
|
Phosphorus Diagnostics LLC
|
Molecular
|
H
| |||
06/04/2020
|
Hangzhou Biotest Biotech Co., Ltd.
|
Serology IgM and IgG
|
H
| |||
06/02/2020
|
Roche Diagnostics
|
Immuno-assay IL-6
|
H, M
| |||
06/01/2020
|
Gravity Diagnostics, LLC
|
Molecular
|
H
| |||
05/29/2020
|
Healgen Scientific LLC
|
Serology IgM and IgG
|
H, M
| |||
05/29/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
05/29/2020
|
Siemens Healthcare Diagnostics Inc.
|
Total Antibody
|
H, M
| |||
05/28/2020
|
PrivaPath Diagnostics, Inc.
|
Molecular
|
H
| |||
05/22/2020
|
dba SpectronRx
|
Molecular
|
H
| |||
05/21/2020
|
BioCore Co., Ltd.
|
Molecular
|
H
| |||
05/21/2020
|
SolGent Co., Ltd.
|
Molecular
|
H
| |||
05/21/2020
|
Seasun Biomaterials, Inc.
|
Molecular
|
H
| |||
05/21/2020
|
P23 Labs, LLC.
|
Molecular
|
H
| |||
05/18/2020
|
Quidel Corporation
|
Molecular
|
H
| |||
05/15/2020
|
Everlywell, Inc.
|
Home Collection Kit
|
N/A
| |||
05/15/2020
|
Fulgent Therapeutics, LLC
|
Molecular
|
H
| |||
05/15/2020
|
Assurance Scientific Laboratories
|
Molecular
|
H
| |||
05/14/2020
|
Hologic, Inc.
|
Molecular
|
H
| |||
05/14/2020
|
GeneMatrix, Inc.
|
Molecular
|
H
| |||
05/13/2020
|
Applied DNA Sciences, Inc.
|
Molecular
|
H
| |||
05/11/2020
|
1drop Inc.
|
Molecular
|
H
| |||
05/11/2020
|
Abbott Molecular Inc.
|
Molecular
|
H, M
| |||
05/08/2020
|
Quidel Corporation
|
Antigen
|
H, M, W
| |||
05/08/2020
|
Gnomegen LLC
|
Molecular
|
H
| |||
05/07/2020
|
Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University
|
Molecular
|
H
| |||
05/07/2020
|
Zymo Research Corporation
|
Molecular
|
H
| |||
05/06/2020
|
OPTI Medical Systems, Inc.
|
Molecular
|
H
| |||
05/06/2020
|
Sherlock BioSciences, Inc.
|
Molecular
|
H
| |||
05/06/2020
|
BioMérieux SA
|
Molecular
|
H
| |||
05/05/2020
|
Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
|
Molecular
|
H
| |||
05/04/2020
|
EUROIMMUN US Inc.
|
Serology IgG
|
H
| |||
05/04/2020
|
Sansure BioTech Inc.
|
Molecular
|
H
| |||
05/02/2020
|
Roche Diagnostics
|
Serology Antibody
|
H, M
| |||
05/01/2020
|
Bio-Rad Laboratories, Inc.
|
Molecular
|
H
| |||
05/01/2020
|
BioFire Diagnostics, LLC
|
Molecular
|
H, M
| |||
04/30/2020
|
Wadsworth Center, New York State Department of Health
|
Serology Total Antibody
|
H
| |||
04/29/2020
|
LabGenomics Co., Ltd.
|
Molecular
|
H
| |||
04/29/2020
|
Rheonix, Inc.
|
Molecular
|
H
| |||
04/29/2020
|
Bio-Rad Laboratories
|
Serology Total Antibody
|
H
| |||
04/27/2020
|
Seasun Biomaterials
|
Molecular
|
H
| |||
04/26/2020
|
Abbott Laboratories Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
DiaSorin Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
Ortho-Clinical Diagnostics, Inc.
|
Serology IgG only
|
H, M
| |||
04/24/2020
|
Autobio Diagnostics Co. Ltd.
|
Serology IgM and IgG
|
H, M
| |||
04/23/2020
|
SD Biosensor, Inc.
|
Molecular
|
H
| |||
04/22/2020
|
altona Diagnostics GmbH
|
Molecular
|
H
| |||
04/21/2020
|
Seegene, Inc.
|
Molecular
|
H
| |||
04/20/2020
|
Trax Management Services Inc.
|
Molecular
|
H
| |||
04/18/2020
|
OSANG Healthcare
|
Molecular
|
H
| |||
04/17/2020
|
Fosun Pharma USA Inc.
|
Molecular
|
H
| |||
04/16/2020
|
KorvaLabs Inc.
|
Molecular
|
H
| |||
04/16/2020
|
GenoSensor, LLC
|
Molecular
|
H
| |||
04/15/2020
|
Maccura Biotechnology (USA) LLC
|
Molecular
|
H
| |||
04/15/2020
|
Mount Sinai Laboratory
|
Serology IgG
|
H
| |||
04/14/2020
|
Ortho Clinical Diagnostics, Inc.
|
Serology Total Antibody
|
H, M
| |||
04/10/2020
|
Atila BioSystems, Inc.
|
Molecular
|
H
| |||
04/08/2020
|
DiaCarta, Inc.
|
Molecular
|
H
| |||
04/08/2020
|
Becton, Dickinson & Company
|
Molecular
|
H, M
| |||
04/07/2020
|
InBios International, Inc.
|
Molecular
|
H
| |||
04/06/2020
|
Gnomegen LLC
|
Molecular
|
H
| |||
04/03/2020
|
Co-Diagnostics, Inc.
|
Molecular
|
H
| |||
04/03/2020
|
ScienCell Research Laboratories
|
Molecular
|
H
| |||
04/03/2020
|
Luminex Corporation
|
Molecular
|
H, M
| |||
04/02/2020
|
Becton, Dickinson & Company (BD)
|
Molecular
|
H, M
| |||
04/01/2020
|
Ipsum Diagnostics, LLC
|
Molecular
|
H
| |||
04/01/2020
|
Cellex Inc.
|
Serology IgM and IgG
|
H, M
| |||
03/30/2020
|
QIAGEN GmbH
|
Molecular
|
H, M
| |||
03/30/2020
|
NeuMoDx Molecular, Inc.
|
Molecular
|
H, M
| |||
03/27/2020
|
Abbott Diagnostics Scarborough, Inc.
|
Molecular
|
H, M, W
| |||
03/27/2020
|
Luminex Molecular Diagnostics, Inc.
|
Molecular
|
H
| |||
03/26/2020
|
BGI Genomics Co. Ltd.
|
Molecular
|
H
| |||
03/25/2020
|
Avellino Lab USA, Inc.
|
Molecular
|
H
| |||
03/24/2020
|
PerkinElmer, Inc.
|
Molecular
|
H
| |||
03/23/2020
|
Mesa Biotech Inc.
|
Molecular
|
H, M, W
| |||
03/23/2020
|
BioFire Defense, LLC
|
Molecular
|
H, M
| |||
03/20/2020
|
Cepheid
|
Molecular
|
H, M, W
| |||
03/20/2020
|
Primerdesign Ltd.
|
Molecular
|
H
| |||
03/19/2020
|
GenMark Diagnostics, Inc.
|
Molecular
|
H, M
| |||
03/19/2020
|
DiaSorin Molecular LLC
|
Molecular
|
H, M
| |||
03/18/2020
|
Abbott Molecular
|
Molecular
|
H
| |||
03/17/2020
|
Quest Diagnostics Infectious Disease, Inc.
|
Molecular
|
H
| |||
03/17/2020
|
Quidel Corporation
|
Molecular
|
H
| |||
03/16/2020
|
Laboratory Corporation of America (LabCorp)
|
Molecular
|
H
| |||
03/16/2020
|
Hologic, Inc.
|
Molecular
|
H
| |||
03/13/2020
|
Thermo Fisher Scientific, Inc.
|
Molecular
|
H
| |||
03/12/2020
|
Roche Molecular Systems, Inc. (RMS)
|
Molecular
|
H, M
| |||
02/29/2020
|
Wadsworth Center, New York State Department of Public Health's (CDC)
|
Molecular
|
H
| |||
02/04/2020
|
Centers for Disease Control and Prevention's (CDC)
|
Molecular
|
H
| |||
1 Authorized settings include the following:
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests:
As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.
Manufacturer Notifications (46):
Laboratories Offering Serology Tests Under the Policy Outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests:
As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:
This policy does not apply to at-home testing, including at-home specimen collection.
The laboratories in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate.
Laboratory Notifications (30):
Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019:
As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:
As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.
This policy does not apply to at-home testing, including at-home specimen collection.
The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate. Commercial manufacturers may also voluntarily withdraw their test notification. For these reasons, the number of tests listed below may change (up or down) on a daily basis.
Manufacturer Notifications (184):
- H - authorized for use in Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
- M - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.
- W - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests, and deemed to be CLIA waived for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests:
As stated in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution to clinical laboratories of diagnostic test kits to perform assays to detect SARS-CoV-2 for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, the believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high-complexity testing, including testing at the point-of-care when the site is covered by the laboratory's CLIA certificate for high-complexity testing. This policy does not apply to at home testing, including at-home specimen collection.
The commercial manufacturers listed below have notified FDA that they have validated and intend to distribute diagnostic test kits as set forth in Section IV.C of the FDA's Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the test, and the test is included in this list to provide transparency regarding the notification submitted to FDA.
Manufacturer Notifications (46):
- AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit
- Agena Bioscience SARS-CoV-2 Panel
- American BioSources Inc., DBA Genomic Diagnostics GDx GrandPerformance SARS-CoV-2 Detection Kit
- BD BioGx SARS-CoV-2 Reagents for BD MAX System (FDA Authorized)
- BGI Genomics Co. Ltd (FDA Authorized)
- Biomeme, Inc. Biomeme SARS-CoV-2 test Kit
- BIONEER Corporation
- BioZentech Co., Ltd., BZ QPCR COVID-19 Kit
- ChromaCode, Inc. HDPCR SARS-CoV-2 Assay
- Co-Diagnostics, Inc. (FDA Authorized)
- Detectachem Inc., MD-Bio BCC19
- ELITechGroup MDx LLC SARS-CoV-2 ELITe MGB Assay
- Enzo Biochem, Inc Enzo AMPIPROBE® SARS-CoV-2 Test System
- Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
- Gencurix Inc. GenePro SARS-CoV-2 Test
- GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
- GeneReach Biotechnology Corporation POCKIT Central SARS-CoV-2
- GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)
- Genomictree, Inc. AccuraDTect SARS-CoV-2-qPCR Kit
- GK Pharmaceuticals Contract Manufacturing Operations, ACCU-RIGHT SARS-COV-2 RT-PCR KIT
- Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay
- GUANGDONG ARDENT BIOMED Co., Ltd, Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)
- Hologic, Inc. Aptima SARS-CoV-2 Assay (FDA Authorized)
- Illucidx Inc., Illucidx COVID-19 Dx RT-LAMP
- LabGenomics, Co., Ltd. LabGun™ COVID-19 Assay Kit (FDA Authorized)
- MatMaCorp, MatMaCorp COVID-19 Test kit (used on the Solas 8)
- Melbourne Biotech MB QRT-PCR TEST SARS-COV2(COVID-19)
- MiCo BioMed Co., Ltd. Veri-Q COVID-19 Multiplex Detection Kit
- Molecular Epidemiology Inc., IEH SARS-CoV-2 RT-PCR Test
- NovaTec Immundiagnosticsa GmBH GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR
- OPTOLANE Technologies Inc. Kaira 2019-nCoV Detection Kit
- OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit (FDA Authorized)
- QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel Assay (FDA Authorized)
- RTA Labs DIAGNOVITAL SARS-CoV-2
- SA Scientific, SAS™ COVID-19 Antibody Detection Test
- SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit
- Solgent Co. Ltd., COVID-19 DiaplexQ Diagnostic Kit (FDA Authorized)
- SUREDX V-CHEK Coronavirus (SARS-CoV-2) Antigen Detection Kit
- Suzhou PreciGenome, Ltd., Co., Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR)
- T2Biosystems, Inc., T2SARS-CoV-2 Panel
- TAAG Genetics S.A. nPLEX SARS-CoV-2 Detection Kit
- Taigen Bioscience Corporation LabTurbo AIO COVID-19 RNA Testing Kit
- Vela Operations Singapore Pte Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0
- VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test
- YD Diagnostics Corp. MolecuTech Real-Time COVID-19
- ZhuHai Sinochips Bioscience Co., Ltd COVID-19 Real-time PCR Test Kit
Laboratories Offering Serology Tests Under the Policy Outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests:
As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This policy does not apply to at-home testing, including at-home specimen collection.
The laboratories in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate.
Laboratory Notifications (30):
- Allermetrix, Inc.
- BioDiagnostic Labs LLC
- Brigham and Women's Hospital
- Center for Cellular Therapy Medical University of South Carolina
- Cincinnati Children's Hospital Medical Center
- CQuentia NGS, LLC
- DLS Research & Ventures
- EDP Biotech Corporation
- Emory Medical Laboratories
- Enzo Clinical Labs
- Ethos Laboratories
- Exsera Biolabs at the University of Colorado Anschutz Medical Campus
- Genalyte, Inc
- IGeneX Inc.
- Immufood, Inc. d/b/a Antibody19
- IMMYLabs
- KSL Diagnostics
- LabCorp Center for Esoteric Testing
- Mayo Clinic
- MEDNA Scientific, Inc.
- OneBlood, Inc.
- Otogenetics
- Phosphorus Diagnostics LLC
- Sciteck Diagnostics
- Stanford Health Care
- Symbiotica, Inc.
- University of Arizona Genetics Core for Clinical Services
- University of Minnesota Advanced Research and Diagnostic Laboratory
- Vibrant America Clinical Labs
- White Coat Sciences
Commercial Manufacturers Distributing Test Kits Under the Policy Outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019:
As stated in Section IV.D of the FDA's Policy for Coronavirus Disease-2019 Tests, the FDA does not intend to object to a commercial manufacturer's development and distribution of serology tests to identify antibodies to SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification to the FDA and information that helps users and patients understand the test results, such as the following, is included in the instructions for use:
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
As noted in the guidance, the FDA believes that 10 business days is a reasonable period of time to prepare an EUA submission for such tests. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.
This policy does not apply to at-home testing, including at-home specimen collection.
The commercial manufacturers in the list below have notified the FDA that they have validated and intend to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. If this designation is not shown, the FDA has not yet reviewed the manufacturer's validation and issued an EUA for the manufacturer's test, and the test is included in this list to provide transparency regarding the notification submitted to the FDA.
If an EUA request is not submitted within a reasonable period of time, or if significant problems are identified with a test and cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from this list, would expect the manufacturer to suspend distribution of the test, and may take additional actions as appropriate. Commercial manufacturers may also voluntarily withdraw their test notification. For these reasons, the number of tests listed below may change (up or down) on a daily basis.
Manufacturer Notifications (184):
- Abbott Laboratories SARS-CoV-2 IgG (for use on ARCHITECT) (FDA Authorized)
- Accel Diagnostics, LLC Rapid C2T Total Ab (IgG/IgM) Card
- Access Bio, Inc. CareStart COVID-19 IgM/IgG
- AI DE Diagnostic Co., Ltd. SARS-CoV-2 IgG/IgM Antibody Test
- Akston Biosciences Corporation AntiCoV-ID IgG ELISA Test
- ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA
- ALPCO SARS-CoV-2 IgG ELISA
- ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA
- ALPCO SARS-CoV-2 IgM ELISA
- Alpha Pharma Service srl IRIS SARS-CoV-2 IgG/IgM Rapid Test
- Ameda Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 IgG/IgM
- AngelWorld Biotech Manufacturing FZ LLC AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test
- Ansh Labs SARS-CoV2 IgG ELISA (AL-1001)
- Ansh Labs SARS-CoV2 IgM ELISA (μ-Capture) (AL-1002)
- Antagen Pharmaceuticals, Inc. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
- Antibody BioPharm, Inc. COVID-19 IgM/IgG POCT Kit (Colloidal Gold)
- Arbor Assays DetectX SARS-CoV-2 IgG ELISA Kit
- Asan Pharmaceutical Co., Ltd. Asan Easy Test COVID-19 IgG/IgM
- Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device (FDA Authorized)
- Aurora Biomed Inc. COVID-19 IgG/IgM Rapid Test Cassette (Colloidal Gold)
- Axium BioResearch, Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test
- Beckman Coulter Access SARS-CoV-2 IgG test (Catalog No. C58961), Access SARS-CoV-2 IgG Calibrators (Catalog No. C58963) and Access SARS-CoV-2 IgG QC (Catalog No. C58964) (FDA Authorized)
- Beijing Beier Bioengineering Co., Ltd 2019-New Coronavirus IgG/IgM Rapid Test Cassette (WB/S/P)
- Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG Antibody Determination Kit
- Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgM Antibody Determination Kit
- Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
- Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit
- Beijing O&D BIOTECH Co., LTD. Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal Gold)
- Beijing Wantai Biological Pharmaceutical Co., Ltd. TOTAL ANTIBODY WANTAI SARS- COV-2 Ab Rapid Test Kit
- Bethyl Laboratories, Inc. Bethyl SARS-CoV-2 IgG IVD ELISA
- Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Cassette Format)
- Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Strip Format)
- BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test
- Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (FDA Authorized)
- Biolidics Limited 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)
- bioMérieux SA VIDAS® SARS-COV-2 IgG
- bioMérieux SA VIDAS® SARS-COV-2 IgM
- Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Novel Coronavirus (2019-nCoV) Antibody Rapid Test
- Biosynex SA Biosynex COVID-19 BSS
- Boditech Med Inc AFIAS COVID-19 Ab serological tests
- Boston Bio Lab Inc. Boston Bio EZ Covid-19
- BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
- Chemtron Biotech, Inc. Chemtrue®Rapid COVID-19 IgM/IgG Antibody Test
- ClearSign Diagnostics Co Novel Coronavirus (SARS-CoV-2) Antibody (IgM/IgG) Test
- Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
- Core Technology Co., Ltd. RapidTest COVID-19 IgM/IgG Ab Test
- Coronacide™ COVID-19 IgM/IgG Rapid Test
- CTK Biotech, Inc. OnSite® COVID-19 IgG/IgM Rapid Test
- DIALAB(ZJG) Biotech Co., Ltd. Device Name: SARS-CoV-2 IgG/IgM Antibody Test (Fluorescence Immunoassay)
- DiaSorin Inc. LIAISON SARS-CoV-2 IgM
- Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit (FDA Authorized)
- Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
- Dynamiker Biotechnology (Tianjin) Co., Ltd. RapidCOV™ 2019-nCOV IgG/IgM Rapid Test
- Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Fluorescence Lateral Flow Immunoassay)
- Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
- Eachy Biopharmaceuticals Co., Ltd. SmartScreen COVID-19 IgM/IgG Test Kit
- Enable Biosciences Inc. ADAP SARS-CoV-2 Total Antibody Assay
- EpiGentek SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit
- Epitope Diagnostics, Inc. EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit Not FDA Authorized H
- Epitope Diagnostics, Inc. KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
- Epitope Diagnostics, Inc. KT-1033 EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit
- ET Healthcare Inc. Pylon COVID-19 IgM/IgG Assay
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA)
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (FDA Authorized)
- Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Rapid Test
- GeneOne Diagnostics Corporation COVID-19 Nucleic Acid Diagnostic Kit
- GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM Rapid Test Kit
- GeneScan Diagnostics, LLC AmeriDx® SARS-CoV-2 IgG/IgM-T Antibody Rapid Test Kit
- Genesprint Group, Ltd. Genesprint Diagnostic Kit for IgG/IgM Antibody to SARS-CoV-2 Test
- Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)
- Gold Standard Diagnostics INgezim® COVID 19 DR ELISA Test Kit
- Goldsite Diagnostics Inc SARS-CoV-2 IgG/IgM Kit
- Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test
- H&Z Life Science Co. Ltd. Anti-COVID-19 Virus IgM/IgG Test Kit (lateral flow assay)
- Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette
- Hangzhou AllTest Biotech Co., Ltd. AllTest COVID IgG/IgM Rapid Test Dipstick
- Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette (FDA Authorized)
- Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette
- Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
- Hangzhou Sejoy Electronics & Instrument Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
- Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) (FDA Authorized)
- HUMASIS Co., Ltd. Humasis COVID-19 IgG/IgM Test
- INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
- Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
- Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
- Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. ThermoGenesis SARS-CoV-2(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)
- Jiangsu Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test (Colloidal Gold)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd. COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
- Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
- LumiQuick Diagnostics, Inc., QuickProfile™ 2019-nCoV IgG/IgM Antibody Test
- Maccura Biotechnology Co., Ltd. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method
- MedicalSystem Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
- MedMira Inc. REVEALCOVID-19™ Total Antibody Test
- Megna Health Inc. Megna Rapid COVID-19 IgG/IgM Combo Test Kit (FDA Authorized)
- Melbourne Biotech MB COVID-19 Antibody Detection Kit
- Micropoint Biosciences, Inc. mLabs® SARS-CoV-2 IgG and IgM Assay
- Mokobio Biotechnology R&D Center Inc COVID-19 IgM & IgG Rapid Test (Colloidal Gold Assay)
- Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
- Multi-G bvba COVID-19 IgG/IgM Rapid Test Cassette
- Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit
- Nanjing Norman Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
- Nanjing SYNTHGENE Medical Technology Co., Ltd. SYNTHGENE COVID-19 IgM/IgG Rapid Detection Kit (Colloidal Gold Method)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test
- NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid Test
- Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
- Naturitious LLC Viralert COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT
- NewScen Coast Bio-Pharmaceutical Co., Ltd. Covid-19 IgG/IgM Rapid Test
- NewScen Coast Bio-Pharmaceutical Co., Ltd. COVID-19 Microfluidic Combo Test
- Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
- Novel Coronavirus (2019-nCoV) IgG/IgM Antibody Testing Kit (Colloidal Gold)
- Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
- Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator (FDA Authorized)
- Pacific Connect Group LLC (US) SARS-CoV-2 IgG/IgM Rapid Test Kit
- PerGrande BioTech Development Co., Ltd. SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)
- Pharmact GmbH, BelTEST It SARS CoV-2 IgM/IgG Rapid Test (Pharmact CoV-2 Rapid Test)
- Plexense, Inc. ACCEL ELISA COVID-19
- Promedical Equipment Pty Ltd Promedical IgM/IgG Rapid Detection Kit
- Promega Corporation Lumit™ Dx SARS-CoV-2 Immunoassay
- Prometheus Bio Inc. 2019-nCoV IgG/IgM Test (Whole blood/Serum/Plasma) Colloidal Gold
- ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM
- Qualigen, Inc. FastPack® SARS-CoV-2 IgG Immunoassay
- Qingdao Hightop Biotech Co., Ltd. HIGHTOP 2019-nCoV IgM/IgG Rapid Test
- Quansys Biosciences Q-Plex™ SARS-CoV-2 Human IgG (4-Plex)
- Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine
- Reszon Diagnostics International Sdn. Bhd. RESZON (COVID-19) (Sars-Cov-2) IgG/IgM Antibody Test
- Ring Biotechnology Co Ltd COVID-19 IgM/IgG Rapid Test Kit
- Roche Diagnostics GmbH Elecsys Anti-SARS-CoV-2 (FDA Authorized)
- SA Scientific Ltd. SAS™ COVID-19 Total Antibody Detection Test
- SA Scientific SAS™ COVID-19 Antibody Detection Test
- Salofa Oy Clarity COVIBLOCK™ COVID-19 IgG/IgM Antibody Test
- Salofa Oy Sienna™ COVID-19 IgG/IgM Rapid Test Cassette
- ScheBo® • Biotech AG ScheBo® • SARS-CoV-2 Quick
- Sciteck Diagnostics COVID19 Automated Antibody Assay
- Sensing Self Pte. Ltd. COVID-19 Rapid IgM/IgG Combined Antibody Assay Pre-Screening Kit<.li>
- Shandong ThinkLab Biotechnology Co., Ltd.: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)
- Shanghai Fosun Long March Medical Science Co., Ltd. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
- Shanghai Liangrun Biomedicine Technology Co., Ltd. Liangrun COVID-19 IgM/IgG Antibody Test
- Shenzhen Lvshiyuan Biotechnology Co., Ltd COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit
- Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit
- Shijiazhuang Hipro Biotechnology Co., Ltd. COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
- ShinJin Medics Inc. DIAKEY COVID-19 IgM/IgG Rapid Test
- Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T) (FDA Authorized)
- Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T) (FDA Authorized)
- Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody Assay (COV2T) (FDA Authorized)
- Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total Antibody Assay (COV2T) (FDA Authorized)
- Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G) (FDA Authorized)
- Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G) (FDA Authorized)
- Singuway Biotech Inc. COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
- Sinocare, Inc. SARS-CoV-2 Antibody Test Kit (Colloidal Gold Method)
- Sober Holdings, LLC COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma)
- Spring Health Care AG COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
- Sunbeam Laboratories, LLC. Sunbeam Laboratories Covid-19 Rapid Test Kit
- SUREDX V-CHEK™ SARS-CoV-2 Antibody Rapid Test Kit
- TBG Biotechnology Corp. SARS-CoV-2 IgG / IgM Rapid Test Kit
- Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test
- Tetracore Inc. Tetracore FlexImmArray SARS-CoV-2 Human IgG Test
- Tianjin New Bay Bioresearch Co., Ltd. Quikpac II COVID-19 IgG/IgM
- Türklab Tibbi Malzemeler San. ve Tic. A.Ş. INFO SARS-CoV-2 IgM/IgG Ab Test
- Türklab Tibbi Malzemeler San. ve Tic. A.Ş. TOYO SARS-CoV-2 IgM/IgG Ab Test
- UC Berkeley Innovative Genomic Institute
- United Biomedical, Inc. UBI® SARS-CoV-2 ELISA
- VicTorch Meditek Inc. COVID-19 IgG/IgM Rapid test Cassette
- VicTorch Meditek Inc. COVID-19 Serology IgG ELISA
- VicTorch Meditek Inc. COVID-19 Serology IgM ELISA
- VirIntel, LLC VirIntel COVID-19 Antibody Test
- Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
- Virotech Diagnostics GmbH Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit
- Vitro Diagnostics Vitro Diagnostics COVID 19 IgG/IgM Rapid Test Cassette Serology Device
- VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
- Vivera Pharmaceuticals, Inc. COVx-RT
- Vivera Pharmaceuticals, Inc. Vivera Pharma COVID-19 Rapid Test
- Wuhan UNscience Biotechnology Co., Ltd. Coronavirus-19 (COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Colloidal gold immunochromatography)
- Wuhu 3H Biotechnology Co. Ltd. COVID-19 IgG/IgM Test Kit (Colloidal Gold Method)
- Xiamen AmonMed Biotechnology Co., Ltd. COVID-19 IgM/IgG test kit (Colloidal Gold)
- Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
- Xiamen Wiz Biotech Co., Ltd. Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2
- Zalgen Labs, LLC. ReSARS CoV-2 (N) IgG ELISA
- ZEUS Scientific, Inc. ELISA SARS-CoV-2 IgG Test System
- ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 Total Antibody Test System
- Zhejiang GENE SCIENCE Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (Latex Chromatography)
- Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
- Zhuhai Keyu Biological Engineering Co., Ltd. SARS-CoV-2 IgG/IgM Rapid Test Kit
- Zybio Inc. SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)
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